Antibiotic Therapy for Early Onset Neonatal Sepsis

Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis

Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

Study Overview

• Status: Recruiting
• Conditions: Early Onset Neonatal Sepsis
• Intervention / Treatment: Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 30000
      • Recruiting
      • Tianjin Central Hospital of Gynecology Obstetrics
      • Sub-Investigator: Xiuying Tian, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates suffered from early onset neonatal sepsis

Description

Inclusion Criteria:

• Age: postnatal age ≤ 72h;
• Meets NICE guidelines for using antibiotics to treat EONS;
• Azlocillin used as part of antimicrobial treatment;
• Parental written consent.

Exclusion Criteria:

• Expected survival time less than the treatment cycle;
• Major congenital malformations;
• Undergoing surgery within the first week of life;
• Receiving other systemic trial drug therapy;
• Other factors that the researcher considers unsuitable for inclusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	requiring additional courses of antibiotic therapy within 72 hours after ending initial antibiotic therapy and/or; progression of the illness, necessitating a change of antibiotic and/or; blood culture isolate reported resistant to the antibiotic.	72 hours after ending initial antibiotic therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 3 days
Treatment duration	Duration of initial antibiotic therapy	Through study completion, an average of 3 days
Duration of hospitalization	Duration of hospitalization of patients	In the first month of patients' life
PD target	The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)	Through study completion, an average of 3 days
White blood cell count	White blood cell count in ×10^9/L	Through study completion, an average of 3 days
Procalcitonin	Procalcitonin in ng/mL	Through study completion, an average of 3 days
C-reactive protein	C-reactive protein in mg/L	Through study completion, an average of 3 days
Death	Death in the first month of life	In the first month of patients' life

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Shandong Provincial Hospital; Qianfoshan Hospital; Tianjin Central Hospital of Gynecology Obstetrics

Publications and helpful links

General Publications

• Wu YE, Wang T, Yang HL, Tang BH, Kong L, Li X, Gao Q, Li X, Yao BF, Shi HY, Huang X, Wang WQ, Jacqz-Aigrain E, Allegaert K, van den Anker J, Tian XY, Zhao W. Population pharmacokinetics and dosing optimization of azlocillin in neonates with early-onset sepsis: a real-world study. J Antimicrob Chemother. 2021 Feb 11;76(3):699-709. doi: 10.1093/jac/dkaa468.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2019
• Primary Completion (ANTICIPATED): October 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (ACTUAL): April 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Vancomycin; Meropenem; Piperacillin; Cefotaxime; Cefoxitin; Tazobactam; Azlocillin
• Other Study ID Numbers: 2019_EOS_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No